At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 532 enrolled
Drug / intervention
Aliskiren +1 moredrug
Likely dose
Aliskiren 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An 8-week Randomized, Double-blind, Parallel-group, Multi-center, Forced-titration Study to Evaluate the Efficacy and Safety of Aliskiren Plus HCTZ Compared to Aliskiren Monotherapy in Metabolic Syndrome Patients With Stage 2 Hypertension
In Brief
A Phase 4 clinical trial evaluating Aliskiren and Hydrochlorothiazide for Hypertension. Completed, enrolled 532 participants across 1 site.
Detailed Summary
The purpose of the study is to evaluate the blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) compared to aliskiren monotherapy when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting systolic blood pressure \[msSBP\] ≥ 160 mm Hg and \< 200 mm Hg).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2008
First PostedNov 2008
Primary CompletionDec 2009
TodayJul 2026
First PostedNov 25, 2008
Enrollment StartNov 1, 2008
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.6 years ago
Interventions
Aliskirendrug
Aliskiren 150 mg or 300 mg taken once daily in oral form
Hydrochlorothiazidedrug
Hydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.